MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-07 for BARD-PARKER STAINLESS STEEL BLADES SIZE 11, STERILE 371211-150 manufactured by Aspen Surgical Products, Caledonia.
[175238802]
Aspen surgical received a report from the distributor indicating that a bard-parker blade broke while in use during a procedure. The incident occurred at the user facility. No sample or photographic evidence was available for evaluation. No manufacturing lot number was provided for review. Bard-parker blade broke off in the patients shoulder. The blade fell off of the blade handle on insertion and then subsequently broke as the physician was attempting to retrieve it. Physician made another incision and was able to visualize the piece and retrieve it. Broken blade was recovered from the patient and was disposed of. Patient is doing well. A review of the device history record could not be completed. The most probable root cause could have been during the stamping or grinding process. Packaging process has established controls to mitigate broken or cracked blade condition, including a "medio" blade sensor that inspects 100% of packed pouches liner level prior to aluminum foil packaging. Also, excessive force applied by end user during surgery process could also cause blade condition. The following controls are in-place to mitigate "broken blade" condition at aspen surgical las piedras site: heat treatment in-process at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test. Heat treatment quality inspections at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test. Based on this information, no additional actions required. Device not available.
Patient Sequence No: 1, Text Type: N, H10
[175238803]
Aspen surgical received a report from the distributor indicating that a bard-parker blade broke during a procedure. The incident occurred at the user facility. This report was filed in our complaint handling system as complaint #(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2020-00002 |
| MDR Report Key | 9557859 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-07 |
| Date of Report | 2019-12-10 |
| Date of Event | 2019-11-26 |
| Date Mfgr Received | 2019-12-10 |
| Date Added to Maude | 2020-01-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JORDAN HACKERT |
| Manufacturer Street | 6945 SOUTHBELT DR. S.E. |
| Manufacturer City | CALEDONIA MI 49316 |
| Manufacturer Country | US |
| Manufacturer Postal | 49316 |
| Manufacturer Phone | 6165367508 |
| Manufacturer G1 | SAME AS ABOVE |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD-PARKER STAINLESS STEEL BLADES SIZE 11, STERILE |
| Generic Name | BARD-PARKER BLADE |
| Product Code | GES |
| Date Received | 2020-01-07 |
| Model Number | 371211-150 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPEN SURGICAL PRODUCTS, CALEDONIA |
| Manufacturer Address | 6945 SOUTHBELT DR. S.E. CALEDONIA MI 49316 US 49316 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-01-07 |